Early Changes of Diabetes Parameters After Obesity Therapy

NCT02553213 | Unknown

• 1 other identifier: Studie_ECODO
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate, if bariatric surgery or the related caloric restriction causes the significant improvement of glucose metabolism, which has been found in bariatric patients.

Conditions

Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (2)

• Change of insulin

  Blood insulin is measured during a Mixed Meal Tolerance Test (MMTT). It is used to calculate the Homeostasis Model Assessment (HOMA) and Matsuda Insulin Sensitivity Index

  Within 5 days after surgery or 5 days after start of caloric restriction

• Change of blood glucose

  Blood glucose is measured during a Mixed Meal Tolerance Test (MMTT). It is used to calculate the Homeostasis Model Assessment (HOMA) and Matsuda Insulin Sensitivity Index

  Within 5 days after surgery or 5 days after start of caloric restriction

Other Outcomes (10)

• Changes regarding markers of glucose metabolism

  Within 5 days after surgery or 5 days after start of caloric restriction

• Changes of body weight

  Within 5 days after surgery or 5 days after start of caloric restriction

• Changes of blood lipids

  Within 5 days after surgery or 5 days after start of caloric restriction

Study Arms (3)

LSG group

EXPERIMENTAL

Laparoscopic sleeve gastrectomy

Other: Laparoscopic sleeve gastrectomy; Other: easy digestible diet

LRYGB group

EXPERIMENTAL

Laparoscopic Roux-en-Y gastric bypass

Other: Laparoscopic Roux-en-Y gastric bypass; Other: easy digestible diet

Control group

OTHER

Caloric restriction

Other: Caloric restriction diet

Interventions

Laparoscopic sleeve gastrectomy OTHER

The surgical procedure and aftercare is indicated and performed according to the routine clinical setting of the Hospital. Patients stay 5 days stationary after surgical treatment. They receive a defined easy digestible diet, starting with liquid and mash food.

LSG group

Laparoscopic Roux-en-Y gastric bypass OTHER

The surgical procedure and aftercare is indicated and performed according to the routine clinical setting of the Hospital. Patients stay 5 days stationary after surgical treatment. They receive a defined easy digestible diet, starting with liquid and mash food.

LRYGB group

Caloric restriction diet OTHER

Patients of the control group do not undergo surgical treatment. They undergo a caloric restriction diet for 5 days. This diet is adapted to the postoperative diet of the patients included in the two other groups.

Control group

easy digestible diet OTHER

LRYGB group; LSG group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI (Body Mass Index) ≥ 35 kg/m2
• Clinical diagnosis of type II diabetes or impaired glucose metabolism (Prediabetes: HbA1c \> 5,7%, fasting glucose in capillary blood \> 110 mg/dl - diagnosed by blood glucose test at the first study examination)
• Regarding the patients of the surgical groups: Indication to surgical therapy of obesity (laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass). The indication to surgery is independent of the study. The surgeon decides about that in the clinical routine according to the German S3 guideline.
• Written consent to participate int he study

You may not qualify if:

• Medication use which affects glucose metabolism, except for diabetes medication (for example: glucocorticoids)
• Insulin need \>1,0 IU/kg/d
• Experimental diabetes medication within the last three months
• Pregnancy
• Gastrointestinal diseases
• Uncontrolled hypo- or hyperthyroidism
• Status after bariatric or other gastrointestinal surgery

Sponsors & Collaborators

• University of Hohenheim: lead
• University Hospital Tuebingen: collaborator
• Karl-Olga-Krankenhaus Stuttgart: collaborator

Study Sites (1)

University of Hohenheim

Stuttgart, Germany

RECRUITING

MeSH Terms

Interventions

Caloric Restriction

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Stephan C. Bischoff, Prof.

  Department of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany

  STUDY CHAIR

• Alfred Königsrainer, Prof.

  Department of General, Visceral, and Transplant Surgery, University Hospital Tübingen, Germany

  STUDY DIRECTOR

Central Study Contacts

Anna Schweinlin

CONTACT

+4971145924880; anna.schweinlin@uni-hohenheim.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2015
• First Posted: September 17, 2015
• Study Start: July 1, 2015
• Primary Completion: May 1, 2019
• Study Completion: July 1, 2019
• Last Updated: May 17, 2018

Record last verified: 2018-05

Locations

DE (1)